TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD

• K Number: K111337
• Device Name: TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
• Manufacturer: TORNIER, INC.
• Date Cleared: 2012-01-25 ( 258 days)
• Product Code: FTL
• Regulation Number: 878.3300
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K070894 , K102788 , K093799 , K073287 , K071887
• Predicate For: N/A

Intended Use

Tornier® Collagen Coated BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Tornier® Collagen Coated BioFiber Scaffold is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.

Tornier® Collagen Coated BioFiber Scaffold is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Device Description

Tornier® Collagen Coated BioFiber™ Scaffold is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile, for single-patient use for the reinforcement of soft tissue where weakness exists.

AI/ML Overview

The provided 510(k) summary for the Tornier® Collagen Coated BioFiber™ Scaffold is for a medical device that is not an AI/ML device, but rather an absorbable surgical mesh. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sensitivity, specificity, F1-score, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.

This 510(k) summary focuses on demonstrating substantial equivalence to predicate surgical meshes through physical, mechanical, biocompatibility, and functionality testing, rather than performance metrics for an AI algorithm.

However, I can extract the relevant information presented in the document based on the prompt's categories, even if they don't perfectly align with AI/ML evaluation.

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Acceptance Criteria and Device Performance (Not Applicable for AI/ML)

Since this is not an AI/ML device, typical performance metrics like sensitivity, specificity, or F1-score are not relevant. The acceptance criteria for this device revolve around demonstrating substantial equivalence to predicate devices through various tests.

The document states: "In support of the claim of substantial equivalence, Tornier has presented data regarding the physical and mechanical characteristics as outlined in the FDA "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh". In addition, Tornier has conducted studies of collagen purity, biocompatibility testing in accord with ISO 10993, a functionality study, a shelf-life study and a biodegradation study."

This indicates that the acceptance criteria would have been met by passing these specific tests and demonstrating that the device performs equivalently to the listed predicate devices in these aspects. The document does not provide specific performance values (e.g., tensile strength, burst strength, degradation rate) to create a table of "reported device performance." Instead, it asserts that the studies support the claim of substantial equivalence.

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Study Details (Adapted for a Non-AI/ML Medical Device)

1. A table of acceptance criteria and the reported device performance

   • Not applicable in the typical AI/ML sense. The acceptance criteria are implicit in the tests conducted to demonstrate substantial equivalence to predicate devices. The document does not provide a table of performance metrics for the Tornier® Collagen Coated BioFiber™ Scaffold versus specific criteria. It only states that the studies were conducted and support substantial equivalence.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not explicitly stated for specific tests. The document mentions a "functionality study," a "shelf-life study," and a "biodegradation study," along with "biocompatibility testing in accord with ISO 10993." However, the sample sizes, data provenance (e.g., animal studies, in-vitro experiments), or study design (retrospective/prospective) for these tests are not detailed in this 510(k) summary. These are typically included in the full submission, not in this publicly available summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. As a physical medical device (surgical mesh), ground truth is established through laboratory testing (e.g., material testing, chemical analysis, animal studies for biocompatibility/biodegradation) and comparison to established standards or predicate device performance, not through expert human review in the context of image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or diagnosis, often to resolve discrepancies in expert opinions for ground truth establishment in AI/ML performance evaluation. This is not relevant for a surgical mesh.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. MRMC studies are used to evaluate diagnostic performance, often for AI-assisted workflows. This device is a surgical mesh, not a diagnostic AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This question pertains to the performance of an AI algorithm in isolation. The Tornier® Collagen Coated BioFiber™ Scaffold is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Derived from laboratory and material testing. For this device, ground truth would be established through:
     • Chemical analysis (for collagen purity).
     • Standardized physical and mechanical tests (e.g., tensile strength, burst strength, weight, porosity) for the mesh material, often following ISO or ASTM standards.
     • Biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation tests) according to ISO 10993 standards, typically involving animal models and histopathological evaluation.
     • Biodegradation studies (in vitro and/or in vivo), also involving animal models and material analysis.
   • The "ground truth" here is the objective measurement of the device's properties and its biological interaction.

8. The sample size for the training set

   • Not applicable. This device is a manufactured product, not an AI model that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. As there is no training set for an AI model, this question is not relevant.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.